About This Course
There’s much to learn when it comes to designing, developing, manufacturing, and selling a thing, but this course skillfully covers it all while teaching how to successfully commercialize a product, too. In Regulated Industry Compliance, students will dig into real-world analysis for regulating production of any kind of product—from a box of breakfast cereal to a medical device.
After this course, you’ll be able to: a) improve efficiency in any part of a product’s lifecycle, b) develop soft skills needed to clearly communicate your ideas for improvement, and c) fully wrap your brain around human factors and customer requirements that must be considered before the product’s development is set. Ultimately, this course teaches and applies methods and techniques that will allow you to step in and make an immediate contribution to improving a company’s processes in any part of the product life cycle you land—beginning, middle, or end. This material has endless application in the workplace.
M.B.A., University of Dallas; B.S., industrial technology, Iowa State University
Mac McKeen is currently a Fellow at Boston Scientific. He has over 25 years of experience in the medical device industry in regulatory and quality roles focused on the development, clinical study, and regulatory approvals of cardiovascular devices. Mac has served as Director of regulatory management for Cardiac Science and St. Jude Medical and the Director of quality and regulatory for Phillips Medisize, a leading contract manufacturer, as well as leadership positions at Medtronic and Guidant. He is actively involved in advocacy and collaboration with the FDA through industry associations including AdvaMed and Medical Alley. He maintains a R.A.C. (Regulatory Affairs Certification).
- MM 4045 - Regulated Industry Compliance
- MM 4193 - Capstone Directed Study